Opioid-use DisorderNCT04289363
Emergency Department Outcomes for Patients With Opioid Use Disorder
An observational study of Opioid-use Disorder, run by NYU Langone Health at 2 sites in United States.
Trial summary
Using mixed methods and triangulating multiples sources of data collected over the course of the parent (CTN-0079 - NCT03544112) and the ancillary studies to evaluate the feasibility, acceptability, sustainability and impact of the emergency department (ED)-initiated Buprenorphine (BUP) clinical program and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- Clinical program implementation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 53 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Nov 2020to 18 Feb 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include ED patients.
Who may be able to join
- Qualitative Population:
- Key stakeholder or opinion leader for ED-initiated BUP
- 18 years of age or older
- Full Study Population \& Limited Study Population:
- Be able to speak English sufficiently to understand study procedures
- Be a potential candidate for ED-initiated BUP by meeting either of the 2 criteria:
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- Clinical determination: patient is a willing and eligible candidate for ED-initiated BUP or for whom this can be reasonably inferred, including any patient who is administered and/or prescribed BUP as part of the index ED visit.
- Research determination: Both a and b below must be true at the time of study enrollment:
- Assessment conducted by an RA indicates that the patient- (all must be true): i. has had nonmedical opioid use within the last 7 days, ii. meets DSM-5 criteria for moderate or severe opioid use disorder (OUD), iii. denies methadone use within 72 hours of ED visit registration, iv. is not engaged in formal medications for opioid use disorder (MOUD) treatment, v. is not prescribed opioids for chronic pain management, vi. reports being interested or "not sure" if interested in receiving BUP as elicited on the ED Health Survey during the index ED visit.
- Absence of clinical documentation associated with the ED visit indicating that the patient is not a candidate for ED-initiated BUP.
Who cannot join
- Qualitative Population:
- Unwilling or unable to provide consent
- currently in jail, prison, or any inpatient overnight facility
- Full Study Population:
- Unwilling or unable to provide written/electronic informed consent
- Currently engaged in formal MOUD treatment at the time of index ED visit
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- Currently in jail, prison or any inpatient overnight facility as required by court of law
- Previous participation as a patient- participant in CTN-0079 or previous participation as a Full Study participant in the current study
- Presents from a medical-based extended care facility
- Current research participant in a substance use intervention study
- Inadequate locator information (unable or unwilling to provide 2 unique means of contact)
- Unable or unwilling to complete research visits at baseline and Day 30.
- Limited Study Population:
- Unwilling or unable to provide written/electronic informed consent
- Currently engaged in formal MOUD treatment at the time of index ED visit
- Currently in jail, prison or any inpatient overnight facility as required by court of law
- Previous participation in the current study as a Limited study or Full study participant
- Presents from a medical-based extended care facility
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Catholic Medical Center
Manchester, New Hampshire, 03102
Bellevue Hospital Center
New York, New York, 10016
About this study
Using mixed methods and triangulating multiples sources of data collected over the course of the parent (CTN-0079 - NCT03544112) and the ancillary studies to evaluate the feasibility, acceptability, sustainability and impact of the emergency department (ED)-initiated Buprenorphine (BUP) clinical program and implementation facilitation strategy and identify factors influencing diffusion and effectiveness.
Read the detailed description
The ancillary study will use mixed-methods combining quantitative and qualitative inquiry (interview/focus group and field notes) with administrative and health record data with some analyses including data collected from the parent CTN-0079 (NCT03544112) study. Further, qualitative data will be analyzed in the context of themes derived from CTN-0069 (NCT03023930) and CTN-0079. CTN-0079-A1 is planned to be conducted at two of the three sites of the parent study: (1) Catholic Medical Center, Manchester, New Hampshire; (2) Bellevue/NYU Health and Hospitals, New York, NY. Many of the methods, operating procedures, measures and forms will be retained or adapted from the parent study. However, CTN-0079-A1 is a new study in which lessons learned through the parent study have informed important design modifications necessary to improve study rigor and utility.
As in the parent study, CTN-0079, all clinical care (BUP and referral) will be delivered as part of each facility's clinical protocol, rather than as a research procedure. Implementation Facilitation (IF) activities will continue during ancillary trial preparation with a more intensive booster of IF activities occurring in the last month prior to trial commencement. Thereafter, all study IF support will cease and ancillary study data collection will begin. Data collection will occur over a course of approximately 12 months, divided into two 6-month study periods - the Post-IF and Maintenance Periods. A period of at least 6 months should separate the beginning of the Maintenance Period from the time of last study intervention.
- Conditions
- Opioid-use Disorder
- Being tested
- Clinical program implementation
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical program implementationBehavioural
Using mixed methods and triangulating multiple sources of data collected over the course of parent and ancillary studies to evaluate the feasibility, acceptability, sustainability, and impact of the ED-initiated BUP clinical program and implementation facilitation strategy and identify factors influencing diffusion and effectiveness. Converging provider and patient perspectives and field notes with process measures and intervention outcomes, including proportions screened, treated, and engaged in treatment, will provide explanation to contextualize and better understand feasibility, acceptability, and factors associated with the rate with which the ED-initiated BUP innovation is adopted and how well it is sustained.
| Study group | Role | What they receive |
|---|---|---|
| ED patients | Administrative and health record data will be examined to assess rates of screening, assessment, eligibility determination, etc. Receives: Behavioral: Clinical program implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Participants Who Received Emergency Department (ED)-Initiated/Expedited Buprenorphine (BUP)
The outcome will be calculated using the following formula: [(Candidates who receive ED-initiated BUP with any disposition) + (Candidates who receive ED-expedited BUP and who are discharged)] / [(Candidates who are discharged) + (Candidates who receive ED-initiated BUP that are not discharged)].
Measured: Up to Month 12
Percent of Participants Who Received ED-Initiated/Expedited BUP Who Were Confirmed to be Engaged in Formal Addiction Treatment for Opioid Use Disorder (OUD) on the 30th Day Following Discharge
The outcome will be calculated using the following formula: (participants who are confirmed to be engaged in formal addiction treatment for Opioid Use Disorder (OUD) on the 30th day following discharge / total number of participants who received ED-initiated/expedited BUP).
Measured: Day 30 Post-Discharge (Up to Month 12)
Secondary outcomes (6)
Percent of Discharged Participants Who Received ED-Initiated BUP
The outcome will be calculated using the following formula: [(ED-initiated, discharged) + (ED-expedited, discharged)] / All candidates who were discharged
Measured: Up to Month 12
Percent of Not-Admitted Participants Who Received ED-Initiated BUP
The outcome will be calculated using the following formula: (ED-initiated, not admitted) /All candidates who were not admitted
Measured: Up to Month 12
Percent of Participants Who Received ED-Initiated BUP
The outcome will be calculated using the following formula: (ED-initiated, all) / [All discharged candidates + (ED-initiated, not discharged)]
Measured: Up to Month 12
Percent of Participants Who Received ED-Initiated/Expedited BUP
The outcome will be calculated using the following formula: (ED-initiated/expedited, all) / [All discharged candidates + (ED-initiated/expedited, not discharged)]
Measured: Up to Month 12
Change in Number of Days of Opioid and/or Other Drug Use as Assessed by Timeline Followback (TLFB) Assessment
The TLFB assessment will elicit the participant's self-reported use of illicit substances over the previous 7 days. At the Day 30 follow-up visit the assessment period will be the 7 days preceding the Day 30 post index ED visit.
Measured: Baseline, Day 30
Change in Number of Self-Reported Opioid-Related Overdose Events
Participants will be asked to report the number of opioid-related overdose events experienced in the past 30 days through a self-report form.
Measured: Baseline, Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start25 Nov 2020
- Primary completion28 Jan 2022
- Study completion18 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Ryan McCormack, MD, MS, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289363
- Sponsor's protocol ID
- 19-01444
- Other IDs
- 3UG1DA013035-18S3
- Status last verified
- Jun 2023
- First submitted
- 26 Feb 2020
- Last updated
- 6 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Department Outcomes for Patients With Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT04289363
- Acronym / sponsor ID
- 19-01444
- Conditions
- Opioid-use Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 28 Jan 2022 (actual)
- Study completion
- 18 Feb 2022 (actual)
- First posted
- 28 Feb 2020 (actual)
- Results
- Posted 6 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Using mixed methods and triangulating multiples sources of data collected over the course of the parent (CTN-0079 - NCT03544112) and the ancillary studies to evaluate the feasibility, acceptability, sustainability and impact of the emergency department (ED)-initiated Buprenorphine (BUP) clinical program and implementation facilitation strategy and identify factors influencing diffusion and effectiveness.
Detailed description
The ancillary study will use mixed-methods combining quantitative and qualitative inquiry (interview/focus group and field notes) with administrative and health record data with some analyses including data collected from the parent CTN-0079 (NCT03544112) study. Further, qualitative data will be analyzed in the context of themes derived from CTN-0069 (NCT03023930) and CTN-0079. CTN-0079-A1 is planned to be conducted at two of the three sites of the parent study: (1) Catholic Medical Center, Manchester, New Hampshire; (2) Bellevue/NYU Health and Hospitals, New York, NY. Many of the methods, operating procedures, measures and forms will be retained or adapted from the parent study. However, CTN-0079-A1 is a new study in which lessons learned through the parent study have informed important design modifications necessary to improve study rigor and utility.
As in the parent study, CTN-0079, all clinical care (BUP and referral) will be delivered as part of each facility's clinical protocol, rather than as a research procedure. Implementation Facilitation (IF) activities will continue during ancillary trial preparation with a more intensive booster of IF activities occurring in the last month prior to trial commencement. Thereafter, all study IF support will cease and ancillary study data collection will begin. Data collection will occur over a course of approximately 12 months, divided into two 6-month study periods - the Post-IF and Maintenance Periods. A period of at least 6 months should separate the beginning of the Maintenance Period from the time of last study intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ED patients | – | Behavioral: Clinical program implementationAdministrative and health record data will be examined to assess rates of screening, assessment, eligibility determination, etc. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include ED patients.
Key inclusion criteria (10 listed)
- Key stakeholder or opinion leader for ED-initiated BUP
- 18 years of age or older
- Be able to speak English sufficiently to understand study procedures
- Be a potential candidate for ED-initiated BUP by meeting either of the 2 criteria:
Key exclusion criteria (18 listed)
- Unwilling or unable to provide consent
- currently in jail, prison, or any inpatient overnight facility
- Unwilling or unable to provide written/electronic informed consent
- Currently engaged in formal MOUD treatment at the time of index ED visit
- Currently in jail, prison or any inpatient overnight facility as required by court of law
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical program implementationUsing mixed methods and triangulating multiple sources of data collected over the course of parent and ancillary studies to evaluate the feasibility, acceptability, sustainability, and impact of the ED-initiated BUP clinical program and implementation facilitation strategy and identify factors influencing diffusion and effectiveness. Converging provider and patient perspectives and field notes with process measures and intervention outcomes, including proportions screened, treated, and engaged in treatment, will provide explanation to contextualize and better understand feasibility, acceptability, and factors associated with the rate with which the ED-initiated BUP innovation is adopted and how well it is sustained. | Behavioural | ED patients |
Primary outcome
Percent of Participants Who Received Emergency Department (ED)-Initiated/Expedited Buprenorphine (BUP)
Time frame: Up to Month 12
The outcome will be calculated using the following formula: [(Candidates who receive ED-initiated BUP with any disposition) + (Candidates who receive ED-expedited BUP and who are discharged)] / [(Candidates who are discharged) + (Candidates who receive ED-initiated BUP that are not discharged)].
Percent of Participants Who Received ED-Initiated/Expedited BUP Who Were Confirmed to be Engaged in Formal Addiction Treatment for Opioid Use Disorder (OUD) on the 30th Day Following Discharge
Time frame: Day 30 Post-Discharge (Up to Month 12)
The outcome will be calculated using the following formula: (participants who are confirmed to be engaged in formal addiction treatment for Opioid Use Disorder (OUD) on the 30th day following discharge / total number of participants who received ED-initiated/expedited BUP).
6 secondary outcomes
Percent of Discharged Participants Who Received ED-Initiated BUP
Time frame: Up to Month 12
Percent of Not-Admitted Participants Who Received ED-Initiated BUP
Time frame: Up to Month 12
Percent of Participants Who Received ED-Initiated BUP
Time frame: Up to Month 12
Percent of Participants Who Received ED-Initiated/Expedited BUP
Time frame: Up to Month 12
Change in Number of Days of Opioid and/or Other Drug Use as Assessed by Timeline Followback (TLFB) Assessment
Time frame: Baseline, Day 30
Change in Number of Self-Reported Opioid-Related Overdose Events
Time frame: Baseline, Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan McCormack, MD, MS principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid-use Disorder, run by NYU Langone Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Participants Who Received Emergency Department (ED)-Initiated/Expedited Buprenorphine (BUP) (time frame: Up to Month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.